A Phase II Open-Label Multi-center Trial of Isotoxic Hypofractionated Radiotherapy for NSCLC

Abstract

Background: The standard treatment for advanced unresectable non-small cell lung cancer (NSCLC) is concurrent chemoradiotherapy. However, many poor Karnofsky score or elderly patients cannot tolerate it due to heir serious side effects. For patients who cannot tolerate concurrent chemoradiotherapy, conventional treatment is sequential chemoradiotherapy or radiotherapy alone. But the median survival time of sequential chemoradiotherapy and radiotherapy alone is 11-16 months. In order to improve curative effect, radiotherapy, as an important treatment method, has been tried, innovated and improved continuously. The goal of this trial is to evaluate feasibility and safety of isotoxic hypofractionated radiotherapy in patients with NSCLC. Methods: This is a phase Ⅱ open-label multi-center two-step non-randomised Trial. In the first stage, 12 patients will be included in the trial with radiotherapy of 3Gy per fraction. If more than 3 patients have serious side effects of radiotherapy, the trial will be terminated. Otherwise, the second phase will continue, and the total number of participants will be 30. All patients eventually will be followed up for 5 years. The primary endpoint is the safety of isotoxic hypofractionated radiotherapy. The secondary outcomes are time to progression (TTP), progression free survival (PFS), overall survival (OS), local control (LC). Discussion: In clinical practice, the local control rate of conventional fractionated radiotherapy for NSCLC is very low. We hope that this trial can verify the safety of isotoxic hypofractionated radiotherapy. Trial Registration: NCT03606291, REGISTERED JULY, 30, 2018.